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| ID | Type | Description | Link |
|---|---|---|---|
| QUE-15-289 | Other Identifier | U.S. Department of Veterans Affairs |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs (VA) Office of Mental Health Operations (OMHO) and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the Center for Disease Control (CDC)'s Replicating Effective Programs plus External Facilitation (REP-F) enhance the adoption of team-based care in VA General Mental Health (GMH) Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans' health status, satisfaction, and perceptions of care? The model for team-based care is the evidence-based Collaborative Chronic Care Model (CCM).
In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary Program team (BHIP) initiative, the investigators have structured a randomized, controlled program evaluation to answer these questions. Specifically, using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.
Based on an internal system-wide review of mental health services and the Mental Health Action Plan submitted to Congress in November, 2011, the Office of Mental Health Operations (OMHO) has undertaken an effort to establish behavioral health interdisciplinary plans (BHIPs), which are intended to provide General Mental Health (GMH) care throughout the Department of Veterans Affairs (VA). The BHIP goal is to build effective interdisciplinary teams, which will provide the majority of care for Veterans in GMH. It is now expected that every Veterans Affairs Medical Center (VAMC) establish at least one BHIP in the current initial phase (begun in late fiscal year 2013), and that the effort scale-up subsequently. Not surprisingly, progress has been uneven.
In 2015 OMHO incorporated the Collaborative Chronic Care Model (CCM) as an evidence-based model by which to structure BHIPs. Consistent with BHIP goals, CCMs were developed to provide anticipatory, continuous, collaborative, evidence-based care. CCMs consist of 6 elements: delivery system redesign, use of clinical information systems, provider decision support, patient self-management support, linkage to community resources, and healthcare organization support. Replicating Effective Programs with External Facilitation (REP-F) has been shown to be effective in implementing complex care models, including CCMs for mental health, both within and beyond VA.
Thus in conjunction with OMHO, the investigators propose this project with the Specific Aim of evaluating the impact of REP-F in implementing CCM-based BHIPs and their effect on Veteran health status. The investigators propose a Hybrid Type III implementation-effectiveness stepped wedge controlled trial, specifically hypothesizing that:
H1: REP-F-based implementation to establish CCM-based BHIPs, compared to existing centralized technical assistance will result in: (H1a) increased Veteran perceptions of CCM-based care, (H1b) higher rates of achieving national BHIP clinical fidelity measures (implementation outcomes), and (H1c) higher provider ratings of the presence of CCM elements.
H2: CCM-based BHIPs, supported by REP-F implementation, will result in improved Veteran health outcomes compared to BHIPs supported by dissemination material alone (intervention outcomes).
The investigators will utilize the national BHIP rollout as a vehicle for this project. Using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation Facilitation | Experimental | Implementation Facilitation consists of the Center for Disease Control's Replicating Effective Programs, plus External Facilitation. The intervention lasts 6 months followed by a 6-month step-down period. |
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| Educational Materials | Placebo Comparator | Dissemination of available materials explaining the Collaborative Chronic Care Model and implementation tools. Sites randomized to delay initiation of facilitation will have these materials plus technical assistance for 4 or 8 months prior to full implementation facilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Replicating Effective Programs plus External Facilitation | Other | Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Veterans RAND-12 Mental Component Score (VR-12 MCS) | Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Veterans RAND-12 Physical Component Scores (VR-12 PCS) | Veterans RAND-Physical Component Score: Overall self-rated physical health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Mental Component Score. | One year |
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Inclusion Criteria:
At least three visits to the General Mental Health Clinic's BHIP team in prior year
Exclusion Criteria:
Chart evidence of dementia
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Bauer, MD | VA Boston Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System | Boston | Massachusetts | 02131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22772364 | Background | Woltmann E, Grogan-Kaylor A, Perron B, Georges H, Kilbourne AM, Bauer MS. Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: systematic review and meta-analysis. Am J Psychiatry. 2012 Aug;169(8):790-804. doi: 10.1176/appi.ajp.2012.11111616. | |
| 23938600 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Veteran Participants | In this stepped wedge design that is not a randomized control trial (RCT), those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject. |
| FG001 | Provider Participants | In this stepped wedge design that is not a randomized control trial (RCT), BHIP team clinicians who participated in team function survey. Primary analyses were within-subject. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Most baseline demographic characteristics of provider participants not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Veteran Participants | In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject. |
| BG001 | Provider Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Veterans RAND-12 Mental Component Score (VR-12 MCS) | Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score. | Adjusted mixed model of single group with repeated event. Number Analyzed = number of participants with available data at the specified time points. 1050 participants completed 1436 interviews across one or more time points: t0, t6, t12. 589 started at t0 (missing=4); 65 added at t6 (missing=1); 386 added at t12 (missing=5). | Posted | Mean | Standard Deviation | score on a scale | one year |
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Full duration of the study from March 2016 through April 2018, approximately 1 year and 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Veteran Participants | Veterans in quasi-experimental stepped wedge design. | 0 |
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All facilities received implementation support, randomized as to start time. There was thus no independent parallel control group. However, several validity checks were conducted to establish internal validity of positive findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark S. Bauer, MD | VA Boston Healthcare System- Center for Healthcare Organization and Implementation Research | 857-364-6380 | mark.bauer@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2018 | Jan 13, 2019 | Prot_SAP_000.pdf |
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| Educational Materials | Other | Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F |
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| Satisfaction Index |
Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72. |
| One year |
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) | Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100. | One year |
| Patient Assessment of Chronic Illness Care (PACIC) | Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33. | One year |
| Team Development Measure (TDM)- Cohesion | Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. | baseline and during stepdown (6-12 months) |
| Team Development Measure (TDM)- Communication | Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure. Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. | baseline and during stepdown (6-12 months) |
| Team Development Measure (TDM)- Role Clarity | Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0). | baseline and during stepdown (6-12 months) |
| Team Development Measure (TDM)- Team Primacy | Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0). | baseline and during stepdown (6-12 months) |
| Mental Health Hospitalization Rates | Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months. | Two years |
| Miller CJ, Grogan-Kaylor A, Perron BE, Kilbourne AM, Woltmann E, Bauer MS. Collaborative chronic care models for mental health conditions: cumulative meta-analysis and metaregression to guide future research and implementation. Med Care. 2013 Oct;51(10):922-30. doi: 10.1097/MLR.0b013e3182a3e4c4. |
| 24129806 | Background | Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039. |
| 33762023 | Derived | Sullivan JL, Kim B, Miller CJ, Elwy AR, Drummond KL, Connolly SL, Riendeau RP, Bauer MS. Collaborative chronic care model implementation within outpatient behavioral health care teams: qualitative results from a multisite trial using implementation facilitation. Implement Sci Commun. 2021 Mar 24;2(1):33. doi: 10.1186/s43058-021-00133-w. |
| 32131824 | Derived | Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3. |
| 31053157 | Derived | Lew RA, Miller CJ, Kim B, Wu H, Stolzmann K, Bauer MS. A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs. Implement Sci. 2019 May 3;14(1):46. doi: 10.1186/s13012-019-0893-3. |
| 30821830 | Derived | Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230. |
| 26912342 | Derived | Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016 Feb 24;11:22. doi: 10.1186/s13012-016-0385-7. |
In this stepped wedge design, BHIP team clinicians who participated in team function survey. Primary analyses were within-subject.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Veteran participants self-reported as one or more races/ethnicities so total exceeds 1050. "Other" includes Alaska Native or Native American, Native Hawaiian or Pacific Islander, Asian, and Other. Minority groups all who reported one or more categories besides "White/Caucasian." Eligible Veterans data not self-reported, from VA Corporate Data Warehouse (CDW). | Provider ethnicity not collected. | Count of Participants | Participants |
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| Marital Status (currently married) | Marital status not collected for providers. | Count of Participants | Participants |
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| Employment Status (full-time, part-time, or self- employed) | Count of Participants | Participants |
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| Rural residence (rural and highly rural) | Residence rurality not collected for providers. | Count of Participants | Participants |
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| Period of service (Gulf War or later, 1990-present) | Military service not collected for providers. | Count of Participants | Participants |
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| VA disability % (>= 50%) | VA disability percentage (amount of disability assigned to VA patients that determines amount of care financially covered by VA). Not collected for providers. | Count of Participants | Participants |
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| Depression or anxiety disorder | Diagnoses not collected for providers. | Count of Participants | Participants |
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| Serious Mental Illness (bipolar spectrum or schizophrenia) | Diagnoses not collected for providers. | Count of Participants | Participants |
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| Post traumatic stress disorder | Diagnoses not collected for providers. | Count of Participants | Participants |
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| Substance use disorder | Diagnoses not collected for providers. | Count of Participants | Participants |
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| Number of active mental health diagnoses (mean + sd) | Diagnoses not collected for providers. | Mean | Standard Deviation | diagnoses |
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| Number of active medical diagnoses (mean + sd) | Diagnoses not collected for providers. | Mean | Standard Deviation | diagnoses |
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| Mental health hospitalization in prior year | Hospitalizations not collected for providers. | Count of Participants | Participants |
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| Medical-surgical hospitalization in prior year | Hospitalizations not collected for providers. | Count of Participants | Participants |
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| Team Development Measure (TDM) | Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0). | Not collected for veterans participants (n=1050). | Mean | Standard Deviation | scores on a scale |
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| Secondary | Veterans RAND-12 Physical Component Scores (VR-12 PCS) | Veterans RAND-Physical Component Score: Overall self-rated physical health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Mental Component Score. | Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 593 started at t0; 66 added at t6; 391 added at t12. None missing from survey. Site included as random effect. | Posted | Mean | Standard Deviation | score on a scale | One year |
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| Secondary | Satisfaction Index | Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72. | Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 576 started at t0 (missing=17); 64 added at t6 (missing=2); 380 added at t12 (missing=11). Site included as random effect. | Posted | Mean | Standard Deviation | score on a scale | One year |
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| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) | Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100. | Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 577 started at t0 (missing=16), 63 added at t6 (missing=3); 380 added at t12 (missing=11). Site included as random effect. | Posted | Mean | Standard Deviation | score on a scale | One year |
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| Secondary | Patient Assessment of Chronic Illness Care (PACIC) | Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33. | Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 582 started at t0 (missing=11); 65 added at t6 (missing=1); 384 added at t12 (missing=7). Site included as random effect. | Posted | Mean | Standard Deviation | score on a scale | One year |
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| Secondary | Team Development Measure (TDM)- Cohesion | Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. | Total 62 mental health providers who completed survey. Number Analyzed = number of participants with available data at the specified time points for Cohesion domain (missing=3). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0. | Posted | Mean | Standard Deviation | score on a scale | baseline and during stepdown (6-12 months) |
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| Secondary | Team Development Measure (TDM)- Communication | Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure. Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. | Total 62 mental health providers who completed survey. Number Analyzed = number of participants with available data and the specified time points for Communication domain (missing=2). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0. | Posted | Mean | Standard Deviation | score on a scale | baseline and during stepdown (6-12 months) |
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| Secondary | Team Development Measure (TDM)- Role Clarity | Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0). | Total 62 mental health providers who completed survey.Number Analyzed = number of participants with available data and the specified time points for Role Clarity domain (missing= 1). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0. | Posted | Mean | Standard Deviation | score on a scale | baseline and during stepdown (6-12 months) |
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| Secondary | Team Development Measure (TDM)- Team Primacy | Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0). | Total 62 mental health providers who completed survey. Number Analyzed = number of participants with available data and the specified time points for Team Primacy (0 missing). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0. | Posted | Mean | Standard Deviation | score on a scale | baseline and during stepdown (6-12 months) |
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| Secondary | Mental Health Hospitalization Rates | Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months. | All eligible patients were coded for hospitalization yes/no in each quarter. | Posted | Least Squares Mean | 95% Confidence Interval | beta coefficient | Two years |
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| 1,050 |
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| 1,050 |
| EG001 | Provider Participants | Providers in mental health (MH) clinics who participated in survey. | 0 | 62 | 0 | 62 | 0 | 62 |
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| Final Twelve Month Timepoint (T12) |
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